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High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinosis

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

High energy density pulse electromagnetic field

sham High energy density pulse electromagnetic field

physiotherapy

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinosis focused on measuring rotator cuff tendinopathy, high energy density pulse electromagnetic field

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age between 20 to 75 years old
persistent shoulder pain for at least 3 months and pain VAS score >=5
positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests
confirmed rotator cuff tendinopathy by ultrasonography or MRI

Exclusion Criteria:

complete or full-thickness tear of rotator cuff found by ultrasonography or MRI
previous shoulder surgery
previous history of severe trauma in shoulder
cervical radiculopathy related shoulder pain or referred pain
other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear
present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout
previous treatment with articular or subacromial steroid injections within the last 3 months
cognitive impairment with loss of ability to sign the agreement and receive rehabilitation
pregnancy or lactating women
has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Sites / Locations

Tri-service general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

physiotherapy and high-PEMF

physiotherapy and sham high-PEMF

Arm Description

The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.

The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.

Outcomes

Primary Outcome Measures

Change in pain Visual Analogue Scale(VAS)

The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

Secondary Outcome Measures

Change in Shoulder Pain and Disability Index (SPADI)

The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings (ADLs) requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80.A higher score shows more disability.

Blood test

Perform blood test to analysis the change of interleukin-1β, interleukin-6, interleukin-10

Blood test

Perform blood test to analysis the change of transforming growth factor-β(TGF-β)

Full Information

NCT ID

NCT05483517

First Posted

July 29, 2022

Last Updated

August 5, 2023

Sponsor

Tri-Service General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05483517

Brief Title

High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

Official Title

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 31, 2023 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy

Detailed Description

Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain. High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz~300MHz) is very different from traditional PEMF. Magnetic field about 50~150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tendinosis

Keywords

rotator cuff tendinopathy, high energy density pulse electromagnetic field

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

physiotherapy and high-PEMF

Arm Type

Experimental

Arm Description

The patient receives physiotherapy under the physiotherapist's guidance and high-PEMF therapy for three weeks, following two sessions a week.

Arm Title

physiotherapy and sham high-PEMF

Arm Type

Sham Comparator

Arm Description

The patient receives physiotherapy under the physiotherapist's guidance and sham high-PEMF therapy for three weeks, following two sessions a week.

Intervention Type

Device

Intervention Name(s)

High energy density pulse electromagnetic field

Intervention Description

The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.

Intervention Type

Device

Intervention Name(s)

sham High energy density pulse electromagnetic field

Intervention Description

The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

Intervention Type

Behavioral

Intervention Name(s)

physiotherapy

Intervention Description

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

Primary Outcome Measure Information:

Title

Change in pain Visual Analogue Scale(VAS)

Description

The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

Time Frame

the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months

Secondary Outcome Measure Information:

Title

Change in Shoulder Pain and Disability Index (SPADI)

Description

Time Frame

the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months

Title

Blood test

Description

Perform blood test to analysis the change of interleukin-1β, interleukin-6, interleukin-10

Time Frame

change from baseline to 1 month

Title

Blood test

Description

Perform blood test to analysis the change of transforming growth factor-β(TGF-β)

Time Frame

change from baseline to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 20 to 75 years old persistent shoulder pain for at least 3 months and pain VAS score >=5 positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests confirmed rotator cuff tendinopathy by ultrasonography or MRI Exclusion Criteria: complete or full-thickness tear of rotator cuff found by ultrasonography or MRI previous shoulder surgery previous history of severe trauma in shoulder cervical radiculopathy related shoulder pain or referred pain other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout previous treatment with articular or subacromial steroid injections within the last 3 months cognitive impairment with loss of ability to sign the agreement and receive rehabilitation pregnancy or lactating women has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang cheng Chen, MD, MS

Phone

886-2-87923311

Ext

12922

clctsgh@yahoo.com.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Chia-Ying Lai, MD

Phone

886-2-87923311

Ext

13606

pokerface165@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liang cheng Chen, MD, MS

Organizational Affiliation

Department of Physical Medicine and Rehabilitation, Tri-Service General

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tri-service general hospital

City

Taipei

State/Province

Neihu

ZIP/Postal Code

11490

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chia-Ying Lai, MD

Phone

886-2-87923311

Ext

13606

pokerface165@gmail.com

12. IPD Sharing Statement

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High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

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